Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Locally-advanced Esophageal Squamous Cell Cancer (RICE) (RICE)

A Phase 2 Trial of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer

This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Chemotherapy; Immunotherapy; Concurrent Chemoradiotherapy; Esophageal Squamous Cell Carcinomas
• Intervention / Treatment: Drug: chemotherapy combined with PD-1 inhibitors

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age:18-75 years of age;
2. Histologically confirmed squamous cell carcinoma;
3. locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery;
4. Eastern Cooperative Oncology Group (ECOG) performance status:0-2;
5. Able to eat a semi-liquid diet;
6. Less than 20% weight loss within 6 months;
7. Adequate hepatic function, renal function, hematologic function and coagulation function;
8. Documented informed consent.

Exclusion Criteria:

1. Distant metastasis;
2. Known malignancy diagnosed or require active treatment in the last 5 years, except for cancers that can be cured by surgery including cervical cancer in situ, basal or squamous cell skin cancer, breast ductal carcinoma in situ, localized prostate cancer;
3. Prior thoracic irradiation, chemotherapy, or lobectomy
4. Known diseases or conditions that are contraindicated for radiotherapy or surgery;
5. Allergy to the research medications;
6. Pregnant women or women preparing for pregnancy;
7. Diagnosis of autoimmune disease or history of chronic autoimmune disease
8. Absence of informed consent because of psychological, family, social and other factors;
9. Patients with comorbidities (chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, unstable mental disorders requiring therapy).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: experimental arm; Two cycles of induction chemotherapy (nab-paclitaxel, 200 mg/m2/day, day1; carboplatin, area under the curve of 5 mg/ml/min, day 1) combined with PD-1 inhibitors （Sintilimab, 200 mg/day, day 1）every 3 weeks followed by concurrent chemoradiotherapy. Patients without progressive disease（PD） will proceed to receive immunotherapy (Sintilimab, 200 mg/day, every 3 weeks) as maintenance treatment for at least 1 year.

Drug: chemotherapy combined with PD-1 inhibitors; Induction chemotherapy combined with PD-1 inhibitors followed with standard concurrent chemoradiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Rate	Overall survival rate is defined as the percentage of participants who are alive up to 3 years from enrollment	3 years after last patient enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free Survival (PFS)	Progression-free survival is defined as the time between date of enrollment and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary tumor site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as PFS events.	3 years after last patient enrolled
Treatment related complications	complications after treatment	During the procedure

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 20, 2022
• Primary Completion (Anticipated): November 19, 2024
• Study Completion (Anticipated): November 19, 2026

Study Registration Dates

• First Submitted: November 5, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: chemotherapy; immunotherapy; esophageal cancer; chemoradiotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Neoplasms, Squamous Cell; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immune Checkpoint Inhibitors
• Other Study ID Numbers: drjunliu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No